Consultation on Proposed Process for Amending the Cosmetic Ingredient 'Hotlist'
October 2006
Purpose
The purpose of this document is to inform industry, the public and other stakeholders about the proposed new process for amending the Cosmetic Ingredient Hotlist.
The Cosmetic Ingredient 'Hotlist'
There are 450+ ingredients on this list which manufacturers must limit, not include, or use under prescribed conditions in cosmetic products. The list is composed of ingredients known to cause adverse health effects, are limited to pharmaceutical applications, or are otherwise of concern in a cosmetic product.
Changes to the Hotlist
Changes to the Hotlist do not undergo an extensive regulatory amendment process. The list is considered to be an elaboration of section 16 of the Food and Drugs Act which states that 'no person shall sell any cosmetic that has in or on it any substance that may cause injury to the health of the user'.
Currently, the list is updated once or twice per year by a Hotlist committee consisting of Cosmetics Division scientists. The group meets on a regular basis to review and discuss ingredients of concern. Conclusions are based on weight of evidence - information is gathered through recognized scientific journals, as well as opinions/decisions on the safety of cosmetic ingredients made by national/international counterparts and expert panel groups.
Current Procedure
- Decision to add ingredient to Hotlist.
- Hotlist is prepared for publication on the web.
- Hotlist is published.
- Letter to company is generated advising them of their options and 60-day notice to respond.
- Company responds and the Hotlist is further amended, if need be.
The current process for Hotlist updates does not offer stakeholders an opportunity to provide comments or share data prior to the list being finalized and published. Therefore, the Cosmetics Division is proposing a new process for amending the Hotlist.
Proposed Procedure
- Decision to add ingredient to Hotlist.
- Proposed Hotlist is prepared for publication on the Web; comment period opens.
- Letters to companies are generated advising them of their options and 60-day notice to respond.
- Company responds or 60-day period expires; comment period closes.
- Official Hotlist is published.
The proposed process offers greater transparency to all stakeholders and affords manufacturers the opportunity to provide data to Health Canada to support the safety of an ingredient.
Hotlist Comment Period
An unofficial version of the revised Hotlist will be posted on the Cosmetics Web site for comment. Companies will have 60 days to review the proposed changes and respond. Provided there are no comments received initiating further review within this time, the proposed Hotlist decisions will become final.
Comment on the Proposed Procedure for Amending the Hotlist
Health Canada welcomes your comments to this proposal, which are to be received no later than November 24, 2006. Once the consultation period is completed and the new process is approved, an updated Winter 2006 draft version of the Cosmetic Ingredient Hotlist will be posted for comment.
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